BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3240369 · Received July 22, 2013

    Report

    Report Number
    2015691-2013-20652
    Event Type
    Death
    Date Received
    July 22, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 25, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, CONDUCTION SYSTEM INJURIES (HEART BLOCK) WHICH MAY REQUIRE A PERMANENT PACEMAKER ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BALLOON AORTIC VALVULOPLASTY, DEPLOYMENT OF THE PROSTHETIC VALVE, AND THE OVERALL TAVR PROCEDURE. IN ADDITION, PER THE IFU HYPOTENSION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE OVERALL TAVR PROCEDURE, INCLUDING VASCULAR AND APICAL ACCESS, USE OF ANGIOGRAPHY, BALLOON VALVULOPLASTY, USE OF CONSCIOUS SEDATION AND/OR GENERAL ANESTHESIA, AND THE BIO-PROSTHESIS IMPLANTATION. ACCORDING TO THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC) GUIDELINES, THE CLOSE ANATOMICAL RELATIONSHIP BETWEEN THE AORTIC VALVE COMPLEX AND THE BRANCHING ATRIOVENTRICULAR BUNDLE MAY PROVIDE AN EXPLANATION FOR THESE COMPLICATIONS OF THE TAVR PROCEDURE. ACCORDING TO LITERATURE REVIEW, AND AS DOCUMENTED IN AN EDWARDS CLINICAL TECHNICAL SUMMARY, ATRIOVENTRICULAR CONDUCTION DISTURBANCES AFTER TAVR ARE ASSOCIATED WITH MANY PATIENT RELATED AND PROCEDURAL RELATED FACTORS, INCLUDING PRE-OPERATIVE CO-MORBID STATUS, THE DEGREE AND BULKINESS OF AORTIC VALVE AND ANNULAR CALCIFICATION, INTER-VENTRICULAR SEPTAL THICKNESS, PRE-EXISTING ELECTROCARDIOGRAM ABNORMALITIES, THE DEPTH OF PROSTHESIS IMPLANTATION, AND THE PROFILE OF THE IMPLANTED PROSTHESIS. UNLIKE CONVENTIONAL AVR, WHERE THERE MAY BE LOCALIZED TRAUMA DUE TO DECALCIFICATION OF THE ANNULUS AND/OR SUTURE PLACEMENT IN THE PROXIMITY OF THE AV NODE OR THE BUNDLES, TAVR MAY CAUSE CONDUCTION ABNORMALITIES THROUGH MECHANICAL IMPINGEMENT OF THE CONDUCTION SYSTEM BY THE PROSTHESIS. THE MECHANISMS OF THE DEVELOPMENT OF HEART BLOCK AFTER TAVR ARE WELL DOCUMENTED AND DESCRIBED IN THE LITERATURE. IT IS ALSO DOCUMENTED THAT PRE-EXISTING HEART BLOCK IS COMMON IN PATIENTS UNDERGOING TAVR OR SURGICAL AVR AND ANOTHER 4-6 % WILL DEVELOP POSTOPERATIVE HEART BLOCK, POTENTIALLY REQUIRING A PERMANENT PACEMAKER. PATIENTS UNDERGOING THE TAVR PROCEDURE CAN BE NON-OPERATIVE OR HIGH RISK, HAVE COMPLEX MEDICAL HISTORIES AND MULTIPLE CO-MORBIDITIES. PATIENT RISK FACTORS FOR HYPOTENSION INCLUDE LOW EF, CAD, CHF, ARTERIOSCLEROSIS, HYPOVOLEMIA, AND ANEMIA. ADDITIONALLY, THESE PATIENTS ARE ROUTINELY ADMINISTERED MULTIPLE VASOACTIVE DRUGS DURING THE PROCEDURE AND ARE INTENTIONALLY MADE HYPOTENSIVE, UTILIZING RAPID VENTRICULAR PACING, TO FACILITATE ACCURATE VALVE DEPLOYMENT. AS A RESULT OF THESE FACTORS, INTRA-OPERATIVE HYPOTENSION IS VERY COMMON AND IS TREATED WITH STANDARD THERAPIES, INCLUDING VASOACTIVE DRUGS. IT IS ALSO NOT UNCOMMON TO INITIATE BRIEF CHEST COMPRESSIONS OR CARDIAC MASSAGE TO FACILITATE DISTRIBUTION OF THESE VASOACTIVE DRUGS. IN SOME CASES, THESE STANDARD MANEUVERS ARE NOT ADEQUATE, AND INITIATION OF CARDIOPULMONARY BYPASS (CPB), INSERTION OF IABP, AND/OR CONVERSION TO OPEN SURGERY IS REQUIRED. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. AS A PRECAUTION, THE THV TRAINING MANUALS INSTRUCT THE OPERATOR TO 1) MINIMIZE THE NUMBER AND DURATION OF RAPID BURST PACING EPISODES, AND 2) ALLOW SUFFICIENT HEMODYNAMIC RECOVERY BEFORE INITIATING ANOTHER EPISODE OF RAPID PACING. ALTHOUGH THE CAUSE OF THE SICK SINUS SYNDROME (SSS) WITH ATRIOVENTRICULAR BLOCK (AV BLOCK) IN THIS CASE CANNOT BE CONFIRMED, IN ADDITION TO THE TAVR PROCEDURE ITSELF, THE SEVERE CALCIFICATION OF THE NATIVE AORTIC VALVE AND THE PATIENT¿S UNDERLYING HEART DISEASE MAY HAVE ALSO CONTRIBUTED TO THE EVENT. ADDITIONALLY, THE CAUSE FOR THE CARDIAC ARREST CANNOT BE CONFIRMED HOWEVER THE RECENT PROCEDURES (TAVR AND PACEMAKER IMPLANTATION) AS WELL AS UNDERLYING PATIENT CO-MORBIDITIES INCLUDING THE SICK SINUS SYNDROME AND AV BLOCK MAY HAVE CAUSED OR CONTRIBUTED TO EVENT. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, THE PATIENT EXPIRED TWO DAYS POST A TRANSAPICAL TAVR PROCEDURE. UPON INVESTIGATION IT WAS LEARNED THAT THE PATIENT HAD A PERMANENT PACEMAKER (PPM) IMPLANTED DUE TO SICK SINUS SYNDROME AND ATRIOVENTRICULAR BLOCK (AV BLOCK) ON THE AFTERNOON FOLLOWING THE TAVR PROCEDURE. LATER THAT NIGHT, THE PATIENT EXPERIENCED A CARDIOPULMONARY ARREST, WHICH RESULTED IN SEVERE HYPOXIC, ISCHEMIC ENCEPHALOPATHY SECONDARY TO THE ARREST. ONE DAY LATER, THE PATIENT DEVELOPED CARDIAC ARREST AND COULD NOT BE RESUSCITATED. THE PATIENT¿S POST OPERATIVE DAY (POD)1TTE SHOWED GOOD SAPIEN VALVE FUNCTION. DURING THE TAVR PROCEDURE, THE 26MM SAPIEN VALVE WAS IMPLANTED IN A 50:50 POSITION ACROSS THE SEVERELY CALCIFIED NATIVE AORTIC ANNULUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341196 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 Death